LITe Plate System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 31, 2014 Stryker Spine Garry Haveck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401 Re: K142699 Trade/Device Name: LITe® Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 2, 2014 Received: October 6, 2014 Dear Dr. Hayeck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K142699 Device Name LITe(R) Plate System ## Indications for Use (Describe) The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifureation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation); Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | | 510(k) Summary: LITe® Plate System | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 | | Contact Person | Garry T. Hayeck, Ph.D.<br>Senior Regulatory Affairs Specialist<br>Phone: 201-760-8043<br>Fax: 201-962-4043<br>E-mail: garry.hayeck@stryker.com | | Date Prepared | December 31, 2014 | | Trade Name | LITe® Plate System | | Common Name | Appliance, fixation, spinal intervertebral body | | Proposed Class | Class II | | Classification Name<br>and Number | Spinal intervertebral body fixation orthosis<br>21 CFR §888.3060 | | Product Code | KWQ | | Predicate Devices | Primary Predicate: Stryker Spine, CENTAUR™ Spinal System, K001844 | | | Additional Predicates: | | | Universal, Sacral, 2 Screw, and 4 Screw Plates | | | • Stryker Spine, CENTAUR™ Spinal System, K994347 | | | • Medtronic, PYRAMID® +4 Anterior Lumbar Plate System, K080429 | | | • NuVasive, Lateral Plate System, K091071 | | | • Spinal USA, Anterior Lumbar Plate System, K091044 | | | • Globus Medical, CITADEL™ Anterior Lumbar Plate System, K062836 | | | • Stryker Spine, THOR Anterior Lumbar Plate, K080773 | | | Buttress Plate | | | • Spinal USA, RCS Anterior Buttress Plate, K092659 | | | • Spinal USA, Anterior Lumbar Plate System, K091044 | | | • Stryker Spine, THOR Anterior Lumbar Plate, K080773 | | Device Description | The LITe® Plate System is an anterior/anterolateral/lateral plate system<br>that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The<br>LITe® Plate System consists of plates and screws manufactured from<br>titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as<br>associated manual general surgical instrumentation. The implants are<br>available in a variety of sizes to accommodate various patient<br>anatomies. | | Intended Use | The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are<br>indicated for use via a lateral or anterolateral surgical approach above<br>the bifurcation of the great vessels in the treatment of the thoracic and<br>thoracolumbar (T1-L5) spine or via an anterior approach below the<br>bifurcation of the great vessels in the treatment of lumbar and<br>lumbosacral (L1-S1) spine. The system is intended to provide additional<br>support during fusion in skeletally mature patients in the treatment of the<br>following acute and chronic instabilities or deformities:<br>• Degenerative Disc Disease (defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by patient history | | 510(k) Summary: LITe® Plate System | | | | Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or Dislocation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis) Failed Previous Fusion | | | The LITe® Plate System Buttress Plate is intended to stabilize the allograft<br>or autograft at one level (T1-S1) as an aid to spinal fusion and to provide<br>temporary stabilization and augment development of a solid spinal<br>fusion. It may be used alone or with other anterior, anterolateral, or<br>posterior spinal systems made of compatible materials. This device is not<br>intended for load bearing applications. | | Summary of the<br>Technological<br>Characteristics | As established in this submission, the LITe® Plate System was shown to<br>be substantially equivalent and have equivalent technological<br>characteristics to its predicate devices through comparison in areas<br>including intended use, material composition, principles of operation<br>and design. | | Summary of the<br>Performance Data | Nonclinical testing was performed to demonstrate that the LITe® Plate<br>System is substantially equivalent to its predicate devices. The following<br>testing and analysis was performed: Static and dynamic compression testing per ASTM F1717-14 Static torsion testing per ASTM F1717-14 Buttress plate expulsion testing | | Conclusions | The LITe® Plate System has identical indications, technological<br>characteristics, and principles of operation as its predicates. The non-<br>clinical test results demonstrate that any minor differences do not<br>impact device performance as compared to the predicates. The LITe®<br>Plate System was shown to be substantially equivalent to its predicate<br>devices. | {4}------------------------------------------------